An observational study in Parkinson's Disease and Hyperprolactinemia, sponsored by Pfizer. Completed. Per ClinicalTrials.gov, last updated 2011-03-23.
Sponsored by Pfizer · Observational
To assess the association between cabergoline and other dopamine agonists (DAs), and symptomatic, diagnosed serious cardiopulmonary disorders, including:
General research practice databases or record linkage systems in Europe that provide access to original medical information. These are: The Health Information Network (THIN), Health Search Database (HSD)-THALES, the Integrated Primary Care Information (IPCI) and PHARMO-Record Linkage System (RLS) and meeting criteria for entry into any of the 4 cohorts between 1995 - 2007
Exclusion Criteria:
All persons who newly start one of the dopamine agonists (DA) after start of eligibility period
Other: Retrospective study-
All persons who started levodopa after start of eligibility period and had not been treated with dopamine agonists anytime prior.
Other: Retrospective study-
All persons with newly diagnosed hyperprolactinemia who had not been treated with dopamine agonists anytime prior.
Other: Retrospective study-
healthy controls from general population matched on age, gender, index date and general practitioner (GP) practice to persons exposed to dopamine agonists
Other: Retrospective study-
Number of Participants With Fibrotic Valvular Heart Disease Per 10,000 Participant-Years of Follow-Up
Occurrence of: mitral stenosis with insufficiency, other unspecified mitral valve diseases, mitral or aortic valve stenosis, insufficiency, or disorders, multiple involvement of mitral and aortic valves, mitral and aortic valve diseases, unspecified, diseases of tricuspid valve, tricuspid valve disorders, specified as nonrheumatic, pulmonary valve disorders, endocarditis, valve unspecified, endomyocardial fibrosis, endocardial fibroelastosis, other primary or secondary cardiomyopathies, cardiomyopathy, functional and undiagnosed cardiac murmurs, other abnormal heart sounds.
Time frame: Up to 12 years
Number of Participants With Fibrosis Per 10,000 Participant-Years of Follow-Up
Occurrence of: idiopathic retroperitoneal fibrosis, occlusion not otherwise specified (NOS) of ureter, diffuse (idiopathic) (interstitial) pulmonary fibrosis, Hamman-Rich syndrome, interstitial pneumonia (desquamative) (lymphoid), fibrosis of lung (atrophic; confluent; massive; perialveolar; peribronchial) chronic or unspecified, pulmonary or pleural fibrosis, abnormal communication between pericardial and pleural sacs, pleural fold anomaly, adhesive or constrictive pericarditis, pericardial fibrosis
Time frame: Up to 12 years
Number of Participants With Heart Failure Per 10,000 Participant-Years of Follow-Up
Occurrence of: unspecified acute edema of lung, heart failure, acute pulmonary heart disease, or acute cor pulmonale
Time frame: Up to 12 years
Number of Participants With All-Cause Mortality Per 10,000 Participant-Years of Follow-Up
All participants who died independent of the cause to include instantaneous death, death occurring in less than 24 hours from onset of symptoms, not otherwise explained, unattended death and other causes of ill defined morbidity and mortality. Cause of death was coded and classified as either cardiovascular or respiratory.
Time frame: Up to 12 years
Noninterventional retrospective cohort study.
| Milestone | Dopamine Agonist (Cohort 1) | Levodopa (Cohort 2) | Hyperprolactinemia (Cohort 3) | Healthy Controls (Cohort 4) |
|---|---|---|---|---|
| Started | 27812 | 14669 | 15147 | 29311 |
| Completed | 27812 | 14669 | 15147 | 29311 |
| Not completed | 0 | 0 | 0 | 0 |
Occurrence of: mitral stenosis with insufficiency, other unspecified mitral valve diseases, mitral or aortic valve stenosis, insufficiency, or disorders, multiple involvement of mitral and aortic valves, mitral and aortic valve diseases, unspecified, diseases of tricuspid valve, tricuspid valve disorders, specified as nonrheumatic, pulmonary valve disorders, endocarditis, valve unspecified, endomyocardial fibrosis, endocardial fibroelastosis, other primary or secondary cardiomyopathies, cardiomyopathy, functional and undiagnosed cardiac murmurs, other abnormal heart sounds.
| Participants/10,000 Participant-Years | Dopamine Agonist (Cohort 1) | Levodopa (Cohort 2) | Hyperprolactinemia (Cohort 3) | Healthy Controls (Cohort 4) |
|---|---|---|---|---|
| Number of Participants With Fibrotic Valvular Heart Disease Per 10,000 Participant-Years of Follow-Up | 21 | 21 | NA | 52 |
Occurrence of: idiopathic retroperitoneal fibrosis, occlusion not otherwise specified (NOS) of ureter, diffuse (idiopathic) (interstitial) pulmonary fibrosis, Hamman-Rich syndrome, interstitial pneumonia (desquamative) (lymphoid), fibrosis of lung (atrophic; confluent; massive; perialveolar; peribronchial) chronic or unspecified, pulmonary or pleural fibrosis, abnormal communication between pericardial and pleural sacs, pleural fold anomaly, adhesive or constrictive pericarditis, pericardial fibrosis
| Participants/10,000 Participant-Years | Dopamine Agonist (Cohort 1) | Levodopa (Cohort 2) | Hyperprolactinemia (Cohort 3) | Healthy Controls (Cohort 4) |
|---|---|---|---|---|
| Number of Participants With Fibrosis Per 10,000 Participant-Years of Follow-Up | 2 | 5 | NA | 8 |
Occurrence of: unspecified acute edema of lung, heart failure, acute pulmonary heart disease, or acute cor pulmonale
| Participants/10,000 Participant-Years | Dopamine Agonist (Cohort 1) | Levodopa (Cohort 2) | Hyperprolactinemia (Cohort 3) | Healthy Controls (Cohort 4) |
|---|---|---|---|---|
| Number of Participants With Heart Failure Per 10,000 Participant-Years of Follow-Up | 69 | 161 | NA | 201 |
All participants who died independent of the cause to include instantaneous death, death occurring in less than 24 hours from onset of symptoms, not otherwise explained, unattended death and other causes of ill defined morbidity and mortality. Cause of death was coded and classified as either cardiovascular or respiratory.
| Participants/10,000 Participant-Years | Dopamine Agonist (Cohort 1) | Levodopa (Cohort 2) | Hyperprolactinemia (Cohort 3) | Healthy Controls (Cohort 4) |
|---|---|---|---|---|
| Number of Participants With All-Cause Mortality Per 10,000 Participant-Years of Follow-Up | 170 | 803 | NA | 719 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dopamine Agonist (Cohort 1) | — | — | — |
| Levodopa (Cohort 2) | — | — | — |
| Hyperprolactinemia (Cohort 3) | — | — | — |
| Healthy Controls (Cohort 4) | — | — | — |
| Age Continuous(years) | Dopamine Agonist (Cohort 1) | Levodopa (Cohort 2) | Hyperprolactinemia (Cohort 3) | Healthy Controls (Cohort 4) | Total |
|---|---|---|---|---|---|
| Mean | 48.7 ± 20.1 | 76.8 ± 0.1 | 40.0 ± 0.1 | 49.4 ± 0.1 | 52.0 ± 21.4 |
| Sex: Female, Male(Participants) | Dopamine Agonist (Cohort 1) | Levodopa (Cohort 2) | Hyperprolactinemia (Cohort 3) | Healthy Controls (Cohort 4) | Total |
|---|---|---|---|---|---|
| Female | 22084 | 7666 | 13398 | 21992 | 65140 |
| Male | 5728 | 7003 | 1749 | 7319 | 21799 |
No study locations are listed for this record.
This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.
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